Health care partner Mark Barnes and corporate associate Minal Caron assisted in the drafting of an article for Bloomberg BNA Life Sciences Law & Industry Report titled, “India’s Proposed Amendments to the Drug and Cosmetics Act: Compensation for Injuries to Clinical Trial participants and the Criminalization of Clinical Research.” Published on Jan. 23, the article examines the provisions of a draft bill, the subject of an invitation for public commentary until January 19, with ramifications for parties conducting and organizing drug and device trials occurring in India.
The article describes the current regulations, adopted in 2013 and amended in 2014, and details the “chilling effect,” that the proposed 2015 reforms could have on the willingness of physicians to conduct trials in India when, under the proposed legislation, they could be exposed to criminal penalties.
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